MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTSCR F/AFN/UFN/CFN+SPIRAL BLADE; MISC ORTHO SURGICAL INSTR

Catalog Number 356.721

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that in 1991, the patient underwent an unknown surgery by using the ufn (unreamed femoral nail) system at another hospital.On (b)(6) 2020, the patient underwent the removal surgery.During the removal surgery, the surgeon could not engage the extraction screw with the top of the nail.After removing the lateral screws, he removed the nail by making an incision at the distal part.The removal surgery was completed with a sixty (60) minute delay.After the surgery, it was confirmed that product code described in the ufn procedure manual was extraction screw (357.360) but product code in the instrument set box was extraction screw (356.721).Later, it was confirmed that the diameter of the tip of the two devices (356.721 and 357.360) are the same.No further information is available.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) extractscr f/afn/ufn/cfn+spiral blade.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: part number: 356.721.Lot number: 2047167.Manufacturing site: bettlach.Release to warehouse date: (b)(6) 2003.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection of the extract screw has shown that the m8 thread the flanks are damaged as well as the locating surface some dents are visible.The tip (m7 thread) shown that no significant traces of use are present.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the complaint is rated as confirmed for this extract screw as the m8 thread flanks are damaged as well as the locating surface some dents visible.The instrument conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The device is older than 17 years and in a used condition, this let us exclude a manufacturing related issue.We can only assume, that this damage can be traced during removal of the nail which indicate that the device was exposed to high loads.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACTSCR F/AFN/UFN/CFN+SPIRAL BLADE
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10515722
• MDR Text Key: 206756067
• Report Number: 8030965-2020-06772
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819281226
• UDI-Public: (01)07611819281226
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.721
• Device Lot Number: 2047167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: FEMORAL; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention